NCT05773703CompletedEarly phase 1
Exploratory PK and Imaging Study of PSMA-Targeted Trillium Compounds and PTI-122 in Metastatic Prostate Cancer
A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy
Source: ClinicalTrials.gov · Last updated 13 Dec 2023
Brief summary (registry, in English)
Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted \[In-111\]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events. Up to four PSMA-Targeted \[In-111\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the \[In-111\]-labeled Trillium Compound may be co-administered with PTI-122.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 23 Feb 2023
- Start date
- 8 Dec 2022
- Primary completion date
- 12 Dec 2023
- Lead sponsor
- Ratio Therapeutics, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT05773703
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 23
- From 8 Dec 2022 to the primary completion date, 12 Dec 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No PSMA-targeted therapy ongoing
- Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)
Other illness
- No other malignancy undergoing treatment
- Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator
Lab values
- Serum creatinine \> 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation
Other
- Inability or unwillingness to undergo SPECT/CT imaging
Who the study is looking for
- Adult males with metastatic prostate cancer
- ECOG performance score 0-2
- Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated
- PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:
- One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR
- Two bone lesions measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ 2 x SUVmax normal liver
- Able to understand and adhere to study requirements, and voluntarily give informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Molecular Imaging & Therapy Coordinator of this site? Confirm its status | Glen Burnie | United States | Unknown status |
| University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Biogenix Molecular Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| XCancer Omaha / Urology Cancer Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.